Bottles for collection or culturing of blood and other biological samples are known in the art. See, e.g., U.S. Pat. Nos. 4,945,060; 5,094,955; 5,860,329; 4,827,944; 5,000,804; 7,211,430 and U.S. Patent Application Publication 2005/0037165.
Sample culture bottles or containers typically contain a headspace gas composition to facilitate the recovery of organisms. The blood culture container is made of a suitable gas-impermeable material to ensure that the integrity of the gas composition in the headspace of the bottle is maintained throughout the shelf life of the bottle. For typical analysis, the container should ideally remain visually optically transmissive, typically transparent, through its life to allow for one or more of (i) manual or electronic observation of the contents of the container, (ii) measuring fill level when using the container, (iii) visual observation of contents after culturing or growth, and (iv) a reading of an internal sensor in the container that detects microbial growth.
Several types of blood culture bottles have been used that limit gas diffusion into or out of the bottle. One type is a glass vial with an elastomeric seal. The glass vial itself provides the gas barrier. However, if a glass vial is dropped it may break, exposing the user to glass shards and, potentially, biologically hazardous materials. Furthermore, the nature of glass manufacturing can leave undetectable micro-cracks in the glass, which under the pressure of microbial growth in the vial can lead to bottle rupturing, and, again, exposure of the user to biohazardous materials.
A second type of blood culture bottle is a multi-layer plastic vial. See, e.g., U.S. Pat. No. 6,123,211 and U.S. Patent Publication 2005/0037165. The multi-layer plastic vial is fabricated from two plastic materials that each serve different functions. For example, the interior and exterior layers of the vials can be produced from polycarbonate, which offers the strength and rigidity required for product use. Likewise, polycarbonate can withstand higher temperatures required for autoclave of the product during manufacture and remains transparent. However, the polycarbonate does not provide a sufficient gas barrier. The middle material layer can be fabricated from nylon, which provides the gas barrier required for the product. The nylon, by itself, does not have the necessary rigidity and strength to withstand the autoclave temperatures required during the manufacture of blood culture bottles, since it would not remain transparent if exposed to moisture or autoclaved. The multilayer plastic vial offers advantages over the glass vials. However, multi-layer plastic vials are produced with relatively complex manufacturing methods and the vials are consequently relatively expensive.
More recently, single layer plastic bottles have been proposed which employs an autoclave or bottle sterilization process to provide the necessary cleanliness/sterility. See, e.g., U.S. Patent Publication No. 2011/0081714, the contents of which are incorporated by reference as if recited in full herein.
Despite the above, there remains a need for cost-effective test sample containers and fabrication methods.